Electrode, Ion Specific, Sodium
FDA product code JGS · Class II (moderate risk) · 21 CFR 862.1665 · Clinical Chemistry
162510(k) clearances
0PMA approvals
43recalls
Manufacturers
- Nova Biomedical Corp. 21
- Medica Corp. 9
- Instrumentation Laboratory CO 5
- Diamond Diagnostics, Inc. 4
- Roche Diagnostics Corp. 4
- Technicon Instruments Corp. 4
- I-Stat Corp. 4
- Shaban Mfg. Co. 4
- Ciba Corning Diagnostics Corp. 4
- American Research Products Co. 4
- Abbott Point Of Care Inc. 3
- Avl Scientific Corp. 3
- Beckman Coulter Inc. 3
- Synermed, Inc. 3
- Amdev, Inc. 3
- Siemens Healthcare Diagnostics, Inc. 3
- Fisher Scientific Co., LLC 3
- Hi Chem, Inc. 3
- Corning Medical & Scientific 2
- Eastman Kodak Company 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252475 | ABL90 FLEX PLUS SystemJGS · Traditional | Radiometer Medicals Aps | 05/01/2026SE |
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl)JGS · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2023SE |
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerJGS · Traditional | Beckman Coulter Laboratory Systems (Suzhou) Co.… | 07/20/2023SE |
| K213486 | GLP systems TrackJGS · Traditional | Abbott Laboratories | 03/10/2022SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 04/14/2020SE |
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 07/19/2019SE |
| K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600JGS · Traditional | Ams Diagnostics | 06/12/2019SE |
| K183549 | GEM Premier ChemSTATJGS · Traditional | Instrumentation Laboratory CO | 02/16/2019SE |
| K180428 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 08/15/2018SE |
| K181201 | Synermed ISE ReagentsJGS · Traditional | Infrared Laboratory Systems, LLC (Dba Synermed) | 07/10/2018SE |
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)JGS · Traditional | Awareness Technology, Inc. | 02/27/2018SE |
| K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH…JGS · Traditional | Siemens Healthcare Diagnostics | 03/09/2017SE |
| K161837 | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerJGS · Traditional | Beckman Coulter, Inc. | 12/16/2016SE |
| K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM…JGS · Traditional | Instrumentation Laboratory CO | 12/14/2016SE |
| K153357 | i-STAT Alinity System with i-STAT Sodium testJGS · Traditional | Abbott Point of Care, Inc. | 07/08/2016SE |
| K160370 | BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer…JGS · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 06/09/2016SE |
| K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A…JGS · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/11/2015SE |
| K140373 | Ise Indirect Na, K, C1 for Gen 2JGS · Traditional | Roche Diagnostics | 05/22/2014SE |
| K132418 | Cobas C 501 Ise Indirect Na, K, CL for Gen. 2JGS · Traditional | Roche Diagnostics | 12/18/2013SE |
| K123726 | Cobas 8000 Ise Indirect Na, K, Ci for Gen. 2JGS · Traditional | Roche Diagnostics | 05/21/2013SE |
| K121140 | Prolyte Electrolyte AnalyzerJGS · Traditional | Diamond Diagnostics, Inc. | 08/22/2012SE |
| K102647 | Elitech Clinical Systems Selectra Prom/Elical 2/ELITROL I and Elitrol Ii/Ast/Got 4+1…JGS · Traditional | Elitechgroup Vital Scientific BV | 03/24/2011SE |
| K102959 | Prolyte Electrolyte AnalyzerJGS · Traditional | Diamond Diagnostics, Inc. | 01/14/2011SE |
| K100829 | Easyra Sodium Assay, Easyra Potassium Assay, Easyra Chloride Assay, Easyra Carbon…JGS · Traditional | Medica Corp. | 01/14/2011SE |
| K100673 | Easylyte Na/K/Cl/Li Analyzer, Model 2020JGS · Special | Medica Corp. | 04/06/2010SE |
| K091861 | Vitros Chemistry Products Na + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…JGS · Special | Ortho-Clinical Diagnostics, Inc. | 09/03/2009SE |
| K082462 | Gemlyte Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+JGS · Traditional | Diamond Diagnostics, Inc. | 02/06/2009SE |
| K081411 | Vitros Chemistry Product Na+ Slides; Vitros Chemistry Products Calibrator Kit 2JGS · Special | Ortho-Clinical Diagnostics, Inc. | 06/30/2008SE |
| K070104 | Prolyte Electrolyte AnalyzerJGS · Traditional | Diamond Diagnostics, Inc. | 05/07/2008SE |
| K061597 | Epoc Blood Analysis SystemJGS · Traditional | Epocal, Inc. | 09/27/2006SE |
| K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge…JGS · Special | I-Stat Corporation | 01/13/2006SE |
| K053165 | Ise Indirect Na, K, CL for GEN.2JGS · Special | Roche Diagnostics Corp. | 12/14/2005SE |
| K052724 | Teco Ise Reagent Set for CX SystemJGS · Traditional | Teco Diagnostics | 12/14/2005SE |
| K051646 | Ise Diluent, 1N KCL, Internal Reference and Ise Standards Low and HighJGS · Traditional | Pointe Scientific, Inc., | 10/07/2005SE |
| K040977 | Genchem Electrolyte BufferJGS · Traditional | Genchem, Inc. | 12/27/2004SE |
| K040971 | Genchem Ise Electrolyte ReferenceJGS · Traditional | Genchem, Inc. | 12/22/2004SE |
| K023049 | Synchron LX I 725 Clinical SystemJGS · Special | Beckman Coulter, Inc. | 10/04/2002SE |
| K020364 | Phoenix Ise Reagents for Beckman CX SystemsJGS · Traditional | Phoenix Diagnostics, Inc. | 06/04/2002SE |
| K011213 | Modification to Synchron LX 20 Clinical Chemistry SystemJGS · Special | Beckman Coulter, Inc. | 05/16/2001SE |
| K002407 | Easyelectrolyte Na/K/Li Analyzer & Rapidlyte Na/K/Li AnalyzerJGS · Traditional | Medica Corp. | 02/02/2001SE |
| K002855 | Biolyte 2000 Na+,K+,Cl-/Li+Electrolyte AnalyzerJGS · Traditional | Biocare Corp. | 10/12/2000SE |
| K001761 | Statlyte Na/K/Cl/Li AnalyzerJGS · Traditional | Nova Biomedical Corp. | 08/07/2000SE |
| K001154 | I-Stat Model 200 Portable Clinical AnalyzerJGS · Special | I-Stat Corp. | 04/18/2000SE |
| K000895 | Stat Profile Phox Plus AnalyzerJGS · Traditional | Nova Biomedical Corp. | 04/17/2000SE |
| K992844 | Hichem Ise Electrolyte BufferJGS · Traditional | Elan Holdings, Inc. | 11/26/1999SE |
| K992842 | Hichem Ise Electrolyte ReferenceJGS · Traditional | Elan Holdings, Inc. | 11/26/1999SE |
| K993211 | Piccolo Sodium Test SystemJGS · Traditional | Abaxis, Inc. | 10/25/1999SE |
| K990346 | Bayer Advia 1650 Chemistry SystemJGS · Traditional | Bayer Corp. | 05/21/1999SE |
| K990036 | Careside Lytes, Careside Anallyzer Model 1000JGS · Traditional | Careside, Inc. | 03/18/1999SE |
| K963763 | Easylyte Sodium/Potassium/Chloride/Lithium AnalyzerJGS · Traditional | Medica Corp. | 11/29/1996SE |
| K963627 | (Modified Version) Integra Ion Selective Electrode (Ise) ModuleJGS · Traditional | Roche Diagnostic Systems, Inc. | 10/24/1996SE |
| K962334 | EML105 Electrolyte Metabolite AnalyzerJGS · Traditional | Radiometer America, Inc. | 10/24/1996SE |
| K963542 | Sigma Diagostic Electrolyte Reference ReagentJGS · Traditional | Sigma Diagnostics, Inc. | 09/27/1996SE |
| K961099 | Ektachem Clinical Chemistry Slide Sodium (Na+)JGS · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 05/07/1996SE |
| K955375 | Easystat Sodium/Potassium AnalyzerJGS · Traditional | Medica Corp. | 02/23/1996SE |
| K955374 | Easystat Sodium/Potassium/Chloride AnalyzerJGS · Traditional | Medica Corp. | 02/23/1996SE |
| K952179 | Synermed Ise ReagentsJGS · Traditional | Synermed, Inc. | 06/20/1995SE |
| K941400 | Synermed Ise ReagentsJGS · Traditional | Synermed, Inc. | 04/26/1994SE |
| K935120 | Eml 100JGS · Traditional | Radiometer America, Inc. | 04/26/1994SE |
| K940194 | Synermed Ise ReagentsJGS · Traditional | Synermed, Inc. | 04/05/1994SE |
| K932179 | Model 400/450 Electrolyte AnalyzerJGS · Traditional | Ionetics, Inc. | 11/17/1993SE |
| K933862 | Ace(Tm) Clin Chem Syst W/Opt Ion Select Electr(Ise)JGS · Traditional | Schiapparelli Biosystems, Inc. | 10/12/1993SE |
| K933373 | Ciba Corning 300 Series SystemJGS · Traditional | Ciba Corning Diagnostics Corp. | 08/19/1993SE |
| K925612 | Hi Chem Electrolyte BufferJGS · Traditional | Hichem Diagnostics | 04/20/1993SE |
| K925611 | Hi Chem Electrolyte Reference ReagentJGS · Traditional | Hichem Diagnostics | 02/23/1993SE |
| K924547 | Nova 8 CRT AnalyzerJGS · Traditional | Nova Biomedical Corp. | 01/28/1993SE |
| K924471 | Kodak Ektachem Clinical Chemistry Slides (Nail)JGS · Traditional | Eastman Kodak Company | 11/06/1992SE |
| K923806 | Analyzer: Nova 10 CRT Analyzer & Quali Cont MaterJGS · Traditional | Nova Biomedical Corp. | 09/29/1992SE |
| K921937 | Nova Nucleus Clinical Chemical Syst, ModificationJGS · Traditional | Nova Biomedical Corp. | 07/27/1992SE |
| K921718 | Olympus Ise ModuleJGS · Traditional | Olympus Corp. | 07/21/1992SE |
| K922215 | Nova 14 Na/K/Cl/Glu/Bun AnalyzerJGS · Traditional | Nova Biomedical Corp. | 07/17/1992SE |
| K915176 | Nova 4 NA/K/C1/TCO2/LI AnalyzerJGS · Traditional | Nova Biomedical Corp. | 01/15/1992SE |
| K914810 | Easylyte Sodium/Potassium/Lithium AnalyzerJGS · Traditional | Medica Corp. | 12/04/1991SE |
| K903564 | Medisensor 2001JGS · Traditional | Medtest Systems, Inc. | 09/30/1991SE |
| K912648 | Ise/Na+JGS · Traditional | Boehringer Mannheim Corp. | 07/17/1991SE |
| K912560 | Nova 12 AnalyzerJGS · Traditional | Nova Biomedical Corp. | 07/17/1991SE |
| K912559 | Nova 1 Sodium/Potassium/Hematocrit AnalyzerJGS · Traditional | Nova Biomedical Corp. | 07/01/1991SE |
| K912387 | I-Stat Model 100 Port Clin Analyzer & Test PackJGS · Traditional | I-Stat Corp. | 07/01/1991SE |
| K912016 | Il Phoenix(Tm), Model 905 Chem/Elect AnalyzerJGS · Traditional | Instrumentation Laboratory CO | 06/10/1991SE |
| K910305 | Gem-Premier SystemJGS · Traditional | Mallinckrodt Sensor Systems, Inc. | 04/03/1991SE |
| K910554 | Clinak(Tm) Ise SubsystemJGS · Traditional | Baxter Healthcare Corp | 03/06/1991SE |
| K905264 | Stat Profile 8 Analyzer,Calibrators and MaterialsJGS · Traditional | Nova Biomedical Corp. | 03/05/1991SE |
| K905600 | Techlyte Electrolyte AnalyzerJGS · Traditional | Technalysis, Inc. | 01/15/1991SE |
| K904335 | Secondary CalibratorsJGS · Traditional | Bionostics, Inc. | 10/12/1990SE |
| K903188 | Abbott Vision Lyte (TM) SodiumJGS · Traditional | Abbott Laboratories | 09/10/1990SE |
| K901042 | Ionometer Ef-Hk and AccessoriesJGS · Traditional | Fresenius USA, Inc. | 07/31/1990SE |
| K901040 | Ionometer Eh-F and AccessoriesJGS · Traditional | Fresenius USA, Inc. | 07/19/1990SE |
| K896526 | Lytening(Tm) 5, Lytening(Tm) System 30JGS · Traditional | Baxter Healthcare Corp | 01/02/1990SE |
| K895936 | Easylyte Sodium/Potassium/Chloride AnalyzerJGS · Traditional | Medica Corp. | 12/12/1989SE |
| K894035 | Eos Chemistry AnalyzerJGS · Traditional | Eos Technology Corp. | 10/31/1989SE |
| K895672 | Technicon Dax System - Sodium (Ise) MethodJGS · Traditional | Technicon Instruments Corp. | 10/25/1989SE |
| K894914 | Model 100 Portable Clinical Analyzer and Test PackJGS · Traditional | I-Stat Corp. | 10/16/1989SE |
| K894218 | Nova Nucleus Clinical Chemistry SystemJGS · Traditional | Nova Biomedical Corp. | 09/07/1989SE |
| K892500 | Ciba Corning Model 570 Alliance I.S.E. ModuleJGS · Traditional | Ciba Corning Diagnostics Corp. | 07/20/1989SE |
| K882801 | Rinse & Reference Solution/Buffer/Low & High Stan.JGS · Traditional | Hf Scientific, Inc. | 08/29/1988SE |
| K882104 | Ion Selective Electrode Subsystem of Para. Analyt.JGS · Traditional | Paramax Systems Div. Baxter Healthcare | 07/05/1988SE |
| K880750 | Nova Stat Profile 6 Analyzer + Quality Control MatJGS · Traditional | Nova Biomedical Corp. | 07/01/1988SE |
| K880917 | Lytening 5JGS · Traditional | Amdev, Inc. | 05/27/1988SE |
| K881255 | Nova 12 NA/K/C1/TOTAL Carbon Dioxide/Glucose/UreaJGS · Traditional | Nova Biomedical Corp. | 05/16/1988SE |
| K874832 | Nova Stat Profile 5 Analyzer + Quality ControlJGS · Traditional | Nova Biomedical Corp. | 02/11/1988SE |
| K875263 | Analytes Sodium & Potassium Assayed on Tech Ra(R)JGS · Traditional | Technicon Instruments Corp. | 02/08/1988SE |
| K874185 | Dart (R) Electrolyte Reagent SystemJGS · Traditional | Coulter Electronics, Inc. | 11/04/1987SE |
| K873126 | Sodium/Potassium Reagent KitJGS · Traditional | A-Kem, Inc. | 10/23/1987SE |
| K873074 | Sodium and Potassium by Ion SelectiveJGS · Traditional | American Monitor Corp. | 10/20/1987SE |
| K872716 | Ciba Corning Model 580 Alliance I.S.E. ModuleJGS · Traditional | Ciba Corning Diagnostics Corp. | 07/31/1987SE |
| K872190 | Nova 13 Sodium/Potassium/Chloride/Lithium AnalyzerJGS · Traditional | Nova Biomedical Corp. | 06/24/1987SE |
| K871028 | Ciba Corning Model 664/FAST 4 SystemJGS · Traditional | Ciba Corning Diagnostics Corp. | 05/28/1987SE |
| K870183 | Ionometer Ef and AccessoriesJGS · Traditional | Smash Ent., Inc. | 05/12/1987SE |
| K864872 | Medica Easylyte Sodium/Potassium AnalyzerJGS · Traditional | Medica Corp. | 03/13/1987SE |
| K864862 | Ref. Membrane for Orion 1020 Sodium/Potassium Ana.JGS · Traditional | Hf Scientific, Inc. | 02/20/1987SE |
| K863907 | Modified Sodium ElectrodeJGS · Traditional | Ionetics, Inc. | 12/10/1986SE |
| K863521 | Lytening 2JGS · Traditional | Amdev, Inc. | 11/05/1986SE |
| K863617 | Ion 2/4 Flow Cell Cleaner (Product #88656)JGS · Traditional | Hi Chem, Inc. | 10/24/1986SE |
| K862819 | Avl Model 984 Electrolyte AnalyzerJGS · Traditional | Avl Scientific Corp. | 08/29/1986SE |
| K861696 | Electrolyte Analyzer Accessory for Hitachi 704JGS · Traditional | Boehringer Mannheim Corp. | 07/01/1986SE |
| K861967 | Amresco Flow Pac Sodium Potassium Reagent SetJGS · Traditional | American Research Products Co. | 06/13/1986SE |
| K861087 | Avl Model 983 Electrolyte AnalyzerJGS · Traditional | Avl Scientific Corp. | 04/07/1986SE |
| K853832 | Lytening 1JGS · Traditional | Amdev, Inc. | 10/04/1985SE |
| K852595 | DC-3 Fluids Pack, DC-5 Fluids PackJGS · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 07/12/1985SE |
| K852473 | Ion-Specific Electrode Option for Cobas FaraJGS · Traditional | Roche Diagnostic Systems, Inc. | 07/12/1985SE |
| K850209 | Quick-LyteJGS · Traditional | Seragen Diagnostics, Inc. | 02/27/1985SE |
| K844587 | Avl Model 982 Electrolyte AnalyzerJGS · Traditional | Avl Scientific Corp. | 01/18/1985SE |
| K844559 | Model 1020 Na+/K+(Sodium/Potassium)Analyzer MultiJGS · Traditional | Thermo Orion | 01/18/1985SE |
| K843530 | Corning 614 Na/K AnalyzerJGS · Traditional | Corning Medical & Scientific | 12/11/1984SE |
| K843453 | Ultra Lyte Sodium Reagent KitJGS · Traditional | Ultra Quest Diagnostics, Inc. | 11/27/1984SE |
| K842873 | Standards & Accessories for Nova InstruJGS · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 10/05/1984SE |
| K843452 | Standard & Solutions for Nova 4 AnalyzJGS · Traditional | Fisher Scientific Co., LLC | 09/27/1984SE |
| K842025 | Ion 4 Sodium/Potassium/Chloride/TotalJGS · Traditional | Hi Chem, Inc. | 06/22/1984SE |
| K841424 | Electrolyte Analyzer SERA-210JGS · Traditional | Horiba Instruments, Inc. | 06/22/1984SE |
| K841418 | Sodium Electrode Rinse Solution 2JGS · Traditional | Reagent Laboratory, Inc. | 05/16/1984SE |
| K841417 | Potassium Chloride Solution -2 MolarJGS · Traditional | Reagent Laboratory, Inc. | 05/16/1984SE |
| K840557 | Reagents & Standards Il 501 Na/KJGS · Traditional | Shaban Mfg. Co. | 04/04/1984SE |
| K833992 | Technicon RA-1000 SystemJGS · Traditional | Technicon Instruments Corp. | 01/24/1984SE |
| K833712 | Na/K Fluida Pack for Nova 1 AnalyzerJGS · Traditional | Fisher Scientific Co., LLC | 01/13/1984SE |
| K833072 | Technicon RA-1000 Sys-Ise Module &JGS · Traditional | Technicon Instruments Corp. | 11/14/1983SE |
| K833036 | Flow-Pac Sodium Reagent SetJGS · Traditional | American Research Products Co. | 11/07/1983SE |
| K832744 | StarlyteJGS · Traditional | Electro-Nucleonics Laboratories, Inc. | 11/03/1983SE |
| K832415 | Deproteinizing & Cleaning SolutionJGS · Traditional | Shaban Mfg. Co. | 09/12/1983SE |
| K832070 | Amresco Na/K Reagent SetJGS · Traditional | American Research Products Co. | 08/12/1983SE |
| K830589 | Electrolyte Standard - Corning Nalk IseJGS · Traditional | Shaban Mfg. Co. | 04/27/1983SE |
| K830588 | Potassium Analyzer-Sodium/ElectrolyteJGS · Traditional | Shaban Mfg. Co. | 04/27/1983SE |
| K822039 | Beckman AstraJGS · Traditional | Beckman Instruments, Inc. | 10/21/1982SE |
| K820395 | Liquizyme Na+/K+ Reagent SetJGS · Traditional | American Research Products Co. | 03/11/1982SE |
| K812762 | Il 501, Na/K AnalyzerJGS · Traditional | Instrumentation Laboratory CO | 10/20/1981SE |
| K811896 | 902 Na/KJGS · Traditional | Corning Medical & Scientific | 07/23/1981SE |
| K811289 | Nova 5JGS · Traditional | Nova Biomedical Corp. | 05/27/1981SE |
| K810135 | Model Am 721 Electrolyte AnalyzerJGS · Traditional | Abbott Diagnostics | 02/10/1981SE |
| K802155 | Reagents Serum Sodium Using the Tech.JGS · Traditional | Panmed, Inc. | 10/10/1980SE |
| K801896 | Beckman ELECTROLYTE-2 Sodium/PotassiumJGS · Traditional | Beckman Instruments, Inc. | 09/16/1980SE |
| K801882 | Nova 4 Sodium/Potassium/Chloride/CarbonJGS · Traditional | Nova Biomedical Corp. | 09/16/1980SE |
| K801795 | Baker Diagnostic Ultra-Rate Sodium/Pot.JGS · Traditional | J.T. Baker Chemical Co. | 09/16/1980SE |
| K801011 | Avl #980 Electrolyte AnalyzerJGS · Traditional | Gauntlet Technology Corp. | 07/08/1980SE |
| K800676 | Reagents for Determ. Sodium in Human SumJGS · Traditional | Diagnostic Solutions, Inc. | 05/28/1980SE |
| K801007 | Il System 502 Na/K AnalyzerJGS · Traditional | Instrumentation Laboratory CO | 05/14/1980SE |
| K800628 | Kodak Ektachem Clinical Chem. SlidesJGS · Traditional | Eastman Kodak Company | 04/10/1980SE |
| K800584 | Nsi Sodium/Potassium KitJGS · Traditional | Nobel Scientific Industries, Inc. | 04/02/1980SE |
| K800216 | Sodium/Potassium Conditioning ReagentJGS · Traditional | Fisher Scientific Co., LLC | 02/26/1980SE |
| K791691 | Sodium/Potassium Conditioning SolutionJGS · Traditional | Hi Chem, Inc. | 09/17/1979SE |
| K771839 | SodiumJGS · Traditional | Gamma Enterprises, Inc. | 11/02/1977SE |
| K770601 | Analyzer, Sodium/Potassium Nova LJGS · Traditional | Nova Biomedical Corp. | 06/14/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2272-2025 Class II | epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test… | Siemens Healthcare Diagnostics Inc | 07/07/2025Open, Classified |
| Z-0423-2024 Class II | RAPIDPOINT 500 Blood Gas SystemThere are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause… | Siemens Healthcare Diagnostics Inc | 09/26/2023Open, Classified |
| Z-0422-2024 Class II | RAPIDPOINT 500e Blood Gas SystemThere are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause… | Siemens Healthcare Diagnostics Inc | 09/26/2023Open, Classified |
| Z-0208-2024 Class II | Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in…Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a… | Nova Biomedical Corporation | 09/18/2023Open, Classified |
| Z-0207-2024 Class II | Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum…Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a… | Nova Biomedical Corporation | 09/18/2023Open, Classified |
| Z-0449-2022 Class II | Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated…(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel… | Siemens Healthcare Diagnostics, Inc. | 11/18/2021Open, Classified |
| Z-2014-2021 Class II | The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an…ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be… | Siemens Healthcare Diagnostics, Inc. | 05/18/2021Terminated |
| Z-2026-2021 Class II | Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of…Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a… | Siemens Healthcare Diagnostics, Inc. | 05/13/2021Open, Classified |
| Z-1870-2021 Class II | Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number:…Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or… | Siemens Healthcare Diagnostics, Inc. | 05/04/2021Open, Classified |
| Z-0861-2021 Class II | Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product…Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results | Siemens Healthcare Diagnostics, Inc. | 12/02/2020Terminated |
| Z-1797-2020 Class II | Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0…Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the… | Siemens Healthcare Diagnostics, Inc. | 02/27/2020Terminated |
| Z-1262-2020 Class II | i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product…The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA… | Abbott Point Of Care Inc. | 01/15/2020Terminated |
| Z-1421-2020 Class II | Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath… | Siemens Healthcare Diagnostics, Inc. | 01/12/2020Open, Classified |
| Z-0921-2020 Class II | ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring…The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user… | Mindray DS USA, Inc. dba Mindray North… | 12/09/2019Terminated |
| Z-0920-2020 Class II | BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas…The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user… | Mindray DS USA, Inc. dba Mindray North… | 12/09/2019Terminated |
| Z-0862-2020 Class II | Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or…On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor… | Siemens Healthcare Diagnostics, Inc. | 10/11/2019Terminated |
| Z-0148-2020 Class II | Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage:…Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below | Siemens Healthcare Diagnostics, Inc. | 07/30/2019Terminated |
| Z-1301-2019 Class II | Atellica Sample Handler Prime, Material Number 11069001There were multiple issues identified in the system software which required an update. | Siemens Healthcare Diagnostics, Inc. | 03/07/2019Terminated |
| Z-0992-2019 Class II | VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use…Imprecision in the affected lot may produce negatively or positively biased patient sample and quality… | Ortho-Clinical Diagnostics | 01/22/2019Terminated |
| Z-3280-2018 Class II | VITROS Sodium Slides, Catalog # 837 9034Potential for positively biased results | Ortho-Clinical Diagnostics | 05/05/2018Terminated |
| Z-1587-2018 Class II | Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of…When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion… | Siemens Healthcare Diagnostics, Inc. | 02/26/2018Terminated |
| Z-1117-2017 Class II | VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+…There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using… | Ortho-Clinical Diagnostics | 12/20/2016Terminated |
| Z-0183-2016 Class II | ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An…ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective… | Siemens Healthcare Diagnostics, Inc. | 08/28/2015Terminated |
| Z-1399-2015 Class II | ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2…Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1.0.2. The… | Siemens Healthcare Diagnostics, Inc. | 02/11/2015Terminated |
| Z-1087-2014 Class II | VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513…Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to… | Ortho-Clinical Diagnostics | 10/17/2013Terminated |
| Z-0816-2014 Class II | ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable…RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on… | Radiometer America Inc | 10/15/2013Terminated |
| Z-0346-2014 Class II | ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries…Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging… | Siemens Healthcare Diagnostics | 09/03/2013Terminated |
| Z-0345-2014 Class II | ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries…Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging… | Siemens Healthcare Diagnostics | 09/03/2013Terminated |
| Z-0344-2014 Class II | ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and…Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging… | Siemens Healthcare Diagnostics | 09/03/2013Terminated |
| Z-0343-2014 Class II | ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and…Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging… | Siemens Healthcare Diagnostics | 09/03/2013Terminated |
| Z-1141-2013 Class II | HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02…HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no… | Horiba Instruments, Inc dba Horiba Medical | 03/20/2013Terminated |
| Z-0158-2020 Class II | Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical…The action was initiated due power supply failure. During a power supply failure the instruments… | Vital Scientific N.V. | 01/10/2012Terminated |
| Z-0157-2020 Class II | Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog #…The action was initiated due power supply failure. During a power supply failure the instruments… | Vital Scientific N.V. | 01/10/2012Terminated |
| Z-2022-2011 | i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a…i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit. | Abbott Point Of Care Inc. | 02/15/2011Terminated |
| Z-2070-2011 | Synchron LX I 725 The Synchron LXi 725 System combines the Synchron LX20 PRO analyzer…This recall was initiated because Beckman Coulter has confirmed that for User-Defined Chemistries (UDRs)… | Beckman Coulter Inc. | 10/22/2010Terminated |
| Z-2385-2008 | SYNCHRON LXi 725 SystemThe field action was initiated after the firm confirmed reports of premature failure of the waste pump… | Beckman Coulter Inc | 04/03/2008Terminated |
| Z-0375-2008 | Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); List No: 06F09-01; Part No:…Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not… | Abbott Point of Care Inc. | 10/18/2007Terminated |
| Z-0374-2008 | Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List…Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not… | Abbott Point of Care Inc. | 10/18/2007Terminated |
| Z-0373-2008 | Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea); List No: 06F10-01; Part No:…Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not… | Abbott Point of Care Inc. | 10/18/2007Terminated |
| Z-0372-2008 | Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct); List No: 06F07-01; Part No:…Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not… | Abbott Point of Care Inc. | 10/18/2007Terminated |
| Z-0371-2008 | Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct); List No: 06F08-01; Part No:…Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not… | Abbott Point of Care Inc. | 10/18/2007Terminated |
| Z-0370-2008 | Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct); List No: 06F05-01…Difficult to Close -- Certian lots of i-STAT cartridges are difficult to close, will not close or do not… | Abbott Point of Care Inc. | 10/18/2007Terminated |
| Z-0119-2008 | OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI…Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age… | Opti Medical Systems Inc | 07/18/2007Terminated |